AbbVie preps an FDA pitch of promising PhIII data for blockbuster hopeful elagolix

Hugh Taylor

AbbVie is rolling out the Phase III data it will deliver to the FDA later this year in search of a blockbuster approval for elagolix, a top late-stage prospect in their pipeline aimed at crippling bouts of endometriosis. And the investigators in the study have put some solid data on display at the 13th World Congress on Endometriosis in Vancouver this afternoon.

In an abstract shared with Endpoints News earlier in the week, AbbVie reported that the drug — an oral gonadotropin-releasing hormone (GnRH) receptor antagonist — demonstrated some clear, dose-dependent responses that easily outpaced the placebo arms in two Phase III trials, each with more than 800 women enrolled in them. Both studies tracked clinical responses for dysmenorrhea — acute and potentially disabling menstrual pain — as well as nonmenstrual pelvic pain.

AbbVie got this drug in a $575 million deal it struck in 2010 with Neurocrine $NBIX, which stands to earn a royalty payout on an approval. Just weeks ago Neurocrine won an approval for Ingrezza (valbenazine) for tardive dyskinesia.

In the first elagolix study the low- and high-dose arms registered a clinical response of 46.4% and 75.8% compared to 19.6% of the placebo arm for dysmenorrhea after three months. The second study delivered remarkably similar results: 43.4% and 72.4% for the low and high doses compared to 22.7% for the placebo arm.

The co-primary endpoint of nonmenstrual pelvic pain also produced a statistically significant response, though the placebo response was markedly higher: 50.4% and 54.5% for the two doses in one trial; 49.8% and 57.8% for the second trial. The placebo patients experienced a 36.5% response.

“That’s exactly what I would have expected,” lead investigator Hugh Taylor tells me. With regular menstrual pain women are more likely to better gauge the drug’s impact, while nonmentrual pelvic pain can be more variable and therefore more likely to leave itself open to the kind of placebo response that many pain drug studies are susceptible to.

Taylor says he routinely treats this ailment in his practice and expects that an approval will usher in a new standard for treating endometriosis.

“It’s not well recognized,” he says, “usual treated (initially) with oral contraceptives, which often don’t work or only partially, with side effects…. Having new options will bring an uptick in recognition.” And with added recognition, he adds, you can expect to find more docs using elagolix.

Right now the general consensus in the medical community is that about 5% to 10% of women in their reproductive years suffer from disabling bouts of this ailment.

Another late-stage program for elagolix has been underway for uterine fibroids, which analysts believe will likely be announced in Q3. The current study for endometriosis is being published in the New England Journal of Medicine.

AbbVie has been moving systematically toward filing the drugs, declaring its second Phase III success for this drug more than a year ago. A spokesperson for the company says the filing will come later this year. And some analysts following the company have tapped it as a drug likely to earn more than a billion dollars a year, marking it as a significant part of AbbVie’s multi-billion dollar effort to prepare for a day when Humira will no longer be able to deliver the bulk of its revenue.

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